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510(k) Data Aggregation

    K Number
    K163432
    Device Name
    Stellar LEAP
    Date Cleared
    2017-06-27

    (202 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG Product Design Group, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stellar LEAP Manual Tilt Wheelchair is intended to provide mobility to persons restricted to a seated position.
    Device Description
    The Stellar LEAP manual tilt wheelchair is an indoor / outdoor, manually operated, Tilt-in-Space wheelchair. Its intended function and use is to provide mobility to persons ages 16 and up (adolescents and adults). The Stellar LEAP manual tilt wheelchair consists of metal frame architecture with a backrest, seat, and rear wheels, which allow for occupant or attendant propelling of the device. Smaller caster wheels are also mounted on the front of the frame to facilitate steering and turning. The Stellar LEAP consists of three (3) metal frame subassemblies: a lower frame, upper seat frame, and sub-frame assembly. The manual Tilt-in-Space operation is achieved using a gas strut mechanism connected between the upper seat frame and sub-frame. The Stellar LEAP Manual Tilt Wheelchair is available in a standard configuration, which allows 20° Tilt-in-Space (posterior) tilt, with a maximum weight capacity of 250 lbs. PDG offers optional features / options to be added to the Stellar LEAP wheelchair, including the two below features: - Stellar LEAP Anterior Tilt Feature (0° 30°): Functional reach extension & transfer . assist - Stellar LEAP Dynamic Recline Backrest Tilt Feature: 30° range of dynamic recline for the backrest combined with the anterior tilt Other available options / accessories to complete the Stellar LEAP configuration include: seat width / depth / height, armrests, casters, frog leg suspension forks, rear wheel / tire, hand rim, wheel locks, anti-tippers, back post style, back options, back upholstery, headrest, tilt control, recline control, front rigging, foot plates, footrest / leg rest accessories, position straps, IV pole, 02 holder.
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    K Number
    K140023
    Device Name
    ELEVATION
    Date Cleared
    2014-10-16

    (283 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.
    Device Description
    The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair. The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning. The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.
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    K Number
    K063736
    Device Name
    FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
    Date Cleared
    2007-01-17

    (30 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide mobility to persons limited to a seated position.
    Device Description
    The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
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    K Number
    K061475
    Device Name
    ASTROTILT MANUAL WHEELCHAIR
    Date Cleared
    2006-06-14

    (15 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide mobility to individuals limited to a sitting position.
    Device Description
    Not Found
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    K Number
    K990557
    Device Name
    THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
    Date Cleared
    1999-03-22

    (28 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the device is in providing mobility to persons restricted to a sitting position.
    Device Description
    The Stellar Tilt, Manually Operated Wheelchair
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    K Number
    K971389
    Device Name
    ECLIPSE 400 MANUALLY OPERATED WHEELCAIR
    Date Cleared
    1997-05-09

    (25 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K970311
    Device Name
    BENTLEY MANUALLY OPERATED WHEELCHAIR
    Date Cleared
    1997-02-14

    (18 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K961743
    Device Name
    ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR
    Date Cleared
    1996-05-29

    (26 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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